NCT07149519

Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women

Impact of Dietary Guidance and Probiotics in the Treatment of Chronic Pelvic Pain Secondary to Endometriosis and Irritable Bowel Syndrome in Women: A Randomized, Double-Blind Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities.

Detailed description

Endometriosis (EDT) is a chronic, inflammatory, hormone-dependent disease that induces cellular adhesion and proliferation, stimulates vascularization, and disrupts protective immune responses. In its intestinal form, endometriosis can lead to abdominal pain, dyschezia, and both cyclic and non-cyclic changes in bowel habits. Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS, which is a disorder characterized by brain-gut interactions and inflammation, presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Anti-inflammatory diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. Given the already documented alteration of the gut microbiota and the female reproductive tract, and their dysbiosis associated with the development of EDT and IBS, the investigators are encouraged to further explore the connection between them. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities. By doing so, the investigators aim to underscore the significance of exploring non-pharmacological treatments and to provide new insights for advancing the understanding and management of endometriosis.

Conditions

• Endometriosis
• Bowels Irritable

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotics - Lactobacillus spp	Group 1: Specific dietary guidance (low-FODMAP diet ) combined with placebo Group 2: Specific dietary guidance (low-FODMAP diet ) combined with probiotic Group 3: Control - Exclusive habitual diet After the 12-week period, we will evaluate the clinical improvement response of pelvic pain

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-06-30
• Completion: 2029-02-15
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: Brazil